Electrocardiography patch

ABSTRACT

An electrocardiography patch is provided. A flexible backing is formed of an elongated strip of stretchable material and a pair of electrodes is respectively affixed on a contact surface of each end of the elongated strip. A flexible circuit is affixed on each end of the elongated strip and includes a pair of circuit traces electrically coupled to each electrode. A non-conductive receptacle is securely adhered on the one end of the elongated strip opposite the contact surface and formed to removably receive an electrocardiography monitor and house a battery. Electrical pads are provided on a bottom surface of the non-conductive receptacle to interface with electrical contacts protruding from the electrocardiography monitor. A pair of the electrical pads is formed to electrically couple with the electrodes. A pair of battery leads is formed on the non-conductive receptacle to electrically interface the battery to another pair of the electrical pads.

CROSS-REFERENCE TO RELATED APPLICATION

This U.S. patent application is a continuation of U.S. patentapplication Ser. No. 14/080,717, filed Nov. 14, 2013, which claimspriority under 35 U.S.C. § 119(e) to U.S. Provisional Patent applicationSer. No. 61/882,403, filed Sep. 25, 2013, the disclosure of which isincorporated by reference.

FIELD

This application relates in general to electrocardiographic monitoringand, in particular, to an electrocardiography patch.

BACKGROUND

The heart emits electrical signals as a by-product of the propagation ofthe action potentials that trigger depolarization of heart fibers. Anelectrocardiogram (ECG) measures and records such electrical potentialsto visually depict the electrical activity of the heart over time.Conventionally, a standardized set format 12-lead configuration is usedby an ECG machine to record cardiac electrical signals fromwell-established traditional chest locations. Electrodes at the end ofeach lead are placed on the skin over the anterior thoracic region ofthe patient's body to the lower right and to the lower left of thesternum, on the left anterior chest, and on the limbs. Sensed cardiacelectrical activity is represented by PQRSTU waveforms that can beinterpreted post-ECG recordation to derive heart rate and physiology.The P-wave represents atrial electrical activity. The QRSTU componentsrepresent ventricular electrical activity.

An ECG is a tool used by physicians to diagnose heart problems and otherpotential health concerns. An ECG is a snapshot of heart function,typically recorded over 12 seconds, that can help diagnose rate andregularity of heartbeats, effect of drugs or cardiac devices, includingpacemakers and implantable cardioverter-defibrillators (ICDs), andwhether a patient has heart disease. ECGs are used in-clinic duringappointments, and, as a result, are limited to recording only thoseheart-related aspects present at the time of recording. Sporadicconditions that may not show up during a spot ECG recording requireother means to diagnose them. These disorders include fainting orsyncope; rhythm disorders, such as tachyarrhythmias andbradyarrhythmias; apneic episodes; and other cardiac and relateddisorders. Thus, an ECG only provides a partial picture and can beinsufficient for complete patient diagnosis of many cardiac disorders.

Diagnostic efficacy can be improved, when appropriate, through the useof long-term extended ECG monitoring. Recording sufficient ECG andrelated physiology over an extended period is challenging, and oftenessential to enabling a physician to identify events of potentialconcern. A 30-day observation day period is considered the “goldstandard” of ECG monitoring, yet achieving a 30-day observation dayperiod has proven unworkable because such ECG monitoring systems arearduous to employ, cumbersome to the patient, and excessively costly.Ambulatory monitoring in-clinic is implausible and impracticable.Nevertheless, if a patient's ECG could be recorded in an ambulatorysetting, thereby allowing the patient to engage in activities of dailyliving, the chances of acquiring meaningful information and capturing anabnormal event while the patient is engaged in normal activities becomesmore likely to be achieved.

For instance, the long-term wear of ECG electrodes is complicated byskin irritation and the inability ECG electrodes to maintain continualskin contact after a day or two. Moreover, time, dirt, moisture, andother environmental contaminants, as well as perspiration, skin oil, anddead skin cells from the patient's body, can get between an ECGelectrode, the non-conductive adhesive used to adhere the ECG electrode,and the skin's surface. All of these factors adversely affect electrodeadhesion and the quality of cardiac signal recordings. Furthermore, thephysical movements of the patient and their clothing impart variouscompressional, tensile, and torsional forces on the contact point of anECG electrode, especially over long recording times, and an inflexiblyfastened ECG electrode will be prone to becoming dislodged. Moreover,dislodgment may occur unbeknownst to the patient, making the ECGrecordings worthless. Further, some patients may have skin that issusceptible to itching or irritation, and the wearing of ECG electrodescan aggravate such skin conditions. Thus, a patient may want or need toperiodically remove or replace ECG electrodes during a long-term ECGmonitoring period, whether to replace a dislodged electrode, reestablishbetter adhesion, alleviate itching or irritation, allow for cleansing ofthe skin, allow for showering and exercise, or for other purpose. Suchreplacement or slight alteration in electrode location actuallyfacilitates the goal of recording the ECG signal for long periods oftime.

Conventionally, Holter monitors are widely used for long-term extendedECG monitoring. Typically, they are often used for only 24-48 hours. Atypical Holter monitor is a wearable and portable version of an ECG thatinclude cables for each electrode placed on the skin and a separatebattery-powered ECG recorder. The cable and electrode combination (orleads) are placed in the anterior thoracic region in a manner similar towhat is done with an in-clinic standard ECG machine. The duration of aHolter monitoring recording depends on the sensing and storagecapabilities of the monitor, as well as battery life. A “looping” Holter(or event) monitor can operate for a longer period of time byoverwriting older ECG tracings, thence “recycling” storage in favor ofextended operation, yet at the risk of losing event data. Althoughcapable of extended ECG monitoring, Holter monitors are cumbersome,expensive and typically only available by medical prescription, whichlimits their usability. Further, the skill required to properly placethe electrodes on the patient's chest hinders or precludes a patientfrom replacing or removing the precordial leads and usually involvesmoving the patient from the physician office to a specialized centerwithin the hospital or clinic.

The ZIO XT Patch and ZIO Event Card devices, manufactured by iRhythmTech., Inc., San Francisco, Calif., are wearable stick-on monitoringdevices that are typically worn on the upper left pectoral region torespectively provide continuous and looping ECG recording. The locationis used to simulate surgically implanted monitors. Both of these devicesare prescription-only and for single patient use. The ZIO XT Patchdevice is limited to a 14-day monitoring period, while the electrodesonly of the ZIO Event Card device can be worn for up to 30 days. The ZIOXT Patch device combines both electronic recordation components andphysical electrodes into a unitary assembly that adheres to thepatient's skin. The ZIO XT Patch device uses adhesive sufficientlystrong to support the weight of both the monitor and the electrodes overan extended period of time and to resist disadherance from the patient'sbody, albeit at the cost of disallowing removal or relocation during themonitoring period. The ZIO Event Card device is a form of downsizedHolter monitor with a recorder component that must be removedtemporarily during baths or other activities that could damage thenon-waterproof electronics. Both devices represent compromises betweenlength of wear and quality of ECG monitoring, especially with respect toease of long term use, female-friendly fit, and quality of atrial(P-wave) signals.

Therefore, a need remains for an extended wear continuously recordingECG monitor practicably capable of being worn for a long period of time,especially in women where breast anatomy can interfere with signalquality in both men and women and capable of recording atrial signalsreliably.

A further need remains for a device capable of recording signals idealfor arrhythmia discrimination, especially a device designed for atrialactivity recording.

SUMMARY

Physiological monitoring can be provided through a wearable monitor thatincludes two components, a flexible extended wear electrode patch and aremovable reusable monitor recorder. The wearable monitor sits centrally(in the midline) on the patient's chest along the sternum orientedtop-to-bottom. The placement of the wearable monitor in a location atthe sternal midline (or immediately to either side of the sternum), withits unique narrow “hourglass”-like shape, significantly improves theability of the wearable monitor to cutaneously sense cardiac electricsignals, particularly the P-wave (or atrial activity) and, to a lesserextent, the QRS interval signals in the ECG waveforms indicatingventricular activity. The electrode patch is shaped to fit comfortablyand conformal to the contours of the patient's chest approximatelycentered on the sternal midline. To counter the dislodgment due tocompressional and torsional forces, a layer of non-irritating adhesive,such as hydrocolloid, is provided at least partially on the underside,or contact, surface of the electrode patch, but only on the electrodepatch's distal and proximal ends. To counter dislodgment due to tensileand torsional forces, a strain relief is defined in the electrodepatch's flexible circuit using cutouts partially extending transverselyfrom each opposite side of the flexible circuit and continuinglongitudinally towards each other to define in ‘S’-shaped pattern. Eachof these components are distinctive and allow for comfortable andextended wear, especially by women, where breast mobility wouldotherwise interfere with monitor use and comfort.

One embodiment provides an extended wear electrocardiography patch. Aflexible backing is formed of an elongated strip of stretchable materialwith a narrow longitudinal midsection evenly tapering inward from bothends. The elongated strip is adherable only on each end of a contactsurface to serve as a crimp relief to facilitate compression of thenarrow longitudinal midsection in response to compressional andtorsional forces. A pair of electrocardiographic electrodes isrespectively affixed to and conductively exposed on the contact surfaceof each end of the elongated strip. A flexible circuit is affixed oneach end to the elongated strip. The flexible circuit includes a pair ofcircuit traces both originating within one of the ends of the elongatedstrip and which are electrically coupled to each electrocardiographicelectrode. A laterally-extendable strain relief is defined in theflexible circuit and formed to facilitate extension and rotation of theflexible circuit in response to tensile and torsional forces. Anon-conductive receptacle is securely adhered on the one end of theelongated strip opposite the contact surface and is formed to removablyreceive an electrocardiography monitor. The non-conductive receptacleincludes electrode terminals aligned to electrically interface the pairof circuit traces to the electrocardiography monitor.

A further embodiment provides an electrocardiography patch. A flexiblebacking is formed of an elongated strip of stretchable material and apair of electrodes is respectively affixed on a contact surface of eachend of the elongated strip. A flexible circuit is affixed on each end ofthe elongated strip and includes a pair of circuit traces electricallycoupled to each electrode. A non-conductive receptacle is securelyadhered on the one end of the elongated strip opposite the contactsurface and formed to removably receive an electrocardiography monitorand house a battery. Electrical pads are provided on a bottom surface ofthe non-conductive receptacle to interface with electrical contactsprotruding from the electrocardiography monitor. A pair of theelectrical pads is formed to electrically couple with the electrodes. Apair of battery leads is formed on the non-conductive receptacle toelectrically interface the battery to another pair of the electricalpads.

The monitoring patch is especially suited to the female anatomy. Thenarrow longitudinal midsection can fit nicely within the intermammarycleft of the breasts without inducing discomfort, whereas conventionalpatch electrodes are wide and, if adhesed between the breasts, wouldcause chafing, irritation, frustration, and annoyance, leading to lowpatient compliance.

The foregoing aspects enhance ECG monitoring performance and qualityfacilitating long-term ECG recording, critical to accurate arrhythmiadiagnosis.

In addition, the foregoing aspects enhance comfort in women (and certainmen), but not irritation of the breasts, by placing the monitoring patchin the best location possible for optimizing the recording of cardiacsignals from the atrium, another feature critical to proper arrhythmiadiagnosis.

Still other embodiments will become readily apparent to those skilled inthe art from the following detailed description, wherein are describedembodiments by way of illustrating the best mode contemplated. As willbe realized, other and different embodiments are possible and theembodiments' several details are capable of modifications in variousobvious respects, all without departing from their spirit and the scope.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are diagrams showing, by way of examples, an extended wearelectrocardiography monitor, including an extended wear electrode patchin accordance with one embodiment, respectively fitted to the sternalregion of a female patient and a male patient.

FIG. 3 is a perspective view showing an extended wear electrode patch inaccordance with one embodiment with a monitor recorder inserted.

FIG. 4 is a perspective view showing the extended wear electrode patchof FIG. 3 without a monitor recorder inserted.

FIG. 5 is a top view showing the flexible circuit of the extended wearelectrode patch of FIG. 3.

FIG. 6 is a perspective view showing the extended wear electrode patchin accordance with a further embodiment.

FIG. 7 is an exploded view showing the component layers of the electrodepatch of FIG. 3.

FIG. 8 is a bottom plan view of the extended wear electrode patch ofFIG. 3 with liner partially peeled back.

DETAILED DESCRIPTION

Physiological monitoring can be provided through a wearable monitor thatincludes two components, a flexible extended wear electrode patch and aremovable reusable monitor recorder. FIGS. 1 and 2 are diagrams showing,by way of examples, an extended wear electrocardiography monitor 12,including an extended wear electrode patch 15 in accordance with oneembodiment, respectively fitted to the sternal region of a femalepatient 10 and a male patient 11. The wearable monitor 12 sits centrally(in the midline) on the patient's chest along the sternum 13 orientedtop-to-bottom with the monitor recorder 14 preferably situated towardsthe patient's head. The electrode patch 15 is shaped to fit comfortablyand conformal to the contours of the patient's chest approximatelycentered on the sternal midline 16 (or immediately to either side of thesternum 13). The distal end of the electrode patch 15 extends towardsthe Xiphoid process and, depending upon the patient's build, maystraddle the region over the Xiphoid process. The proximal end of theelectrode patch 15, located under the monitor recorder 14, is below themanubrium and, depending upon patient's build, may straddle the regionover the manubrium.

The placement of the wearable monitor 12 in a location at the sternalmidline 16 (or immediately to either side of the sternum 13)significantly improves the ability of the wearable monitor 12 tocutaneously sense cardiac electric signals, particularly the P-wave (oratrial activity) and, to a lesser extent, the QRS interval signals inthe ECG waveforms that indicate ventricular activity. The sternum 13overlies the right atrium of the heart and the placement of the wearablemonitor 12 in the region of the sternal midline 13 puts the ECGelectrodes of the electrode patch 15 in a location better adapted tosensing and recording P-wave signals than other placement locations,say, the upper left pectoral region. In addition, placing the lower orinferior pole (ECG electrode) of the electrode patch 15 over (or near)the Xiphoid process facilitates sensing of right ventricular activityand provides superior recordation of the QRS interval.

During use, the electrode patch 15 is first adhesed to the skin alongthe sternal midline 16 (or immediately to either side of the sternum13). A monitor recorder 14 is then snapped into place on the electrodepatch 15 to initiate ECG monitoring. FIG. 3 is a perspective viewshowing an extended wear electrode patch 15 in accordance with oneembodiment with a monitor recorder 14 inserted. The body of theelectrode patch 15 is preferably constructed using a flexible backing 20formed as an elongated strip 21 of wrap knit or similar stretchablematerial about 145 mm long and 32 mm at the widest point with a narrowlongitudinal mid-section 23 evenly tapering inward from both sides. Apair of cut-outs 22 between the distal and proximal ends of theelectrode patch 15 create a narrow longitudinal midsection 23 or“isthmus” and defines an elongated “hourglass”-like shape, when viewedfrom above, such as described in commonly-assigned U.S. Design Patentapplication, entitled “Extended Wear Electrode Patch,” Ser. No.29/472,045, filed Nov. 7, 2013, the disclosure of which is incorporatedby reference. The upper part of the “hourglass” is sized to allow anelectrically non-conductive receptacle 25, sits on top of theoutward-facing surface of the electrode patch 15, to be affixed to theelectrode patch 15 with an ECG electrode placed underneath on thepatient-facing underside, or contact, surface of the electrode patch 15;the upper part of the “hourglass” has a longer and wider profile thanthe lower part of the “hourglass,” which is sized primarily to allowjust the placement of an ECG electrode.

The electrode patch 15 incorporates features that significantly improvewearability, performance, and patient comfort throughout an extendedmonitoring period. During wear, the electrode patch 15 is susceptible topushing, pulling, and torquing movements, including compressional andtorsional forces when the patient bends forward, and tensile andtorsional forces when the patient leans backwards. To counter thesestress forces, the electrode patch 15 incorporates crimp and strainreliefs, as further described infra respectively with reference to FIGS.4 and 5. In addition, the cut-outs 22 and longitudinal midsection 23help minimize interference with and discomfort to breast tissue,particularly in women (and gynecomastic men). The cut-outs 22 andlongitudinal midsection 23 allow better conformity of the electrodepatch 15 to sternal bowing and to the narrow isthmus of flat skin thatcan occur along the bottom of the intermammary cleft between thebreasts, especially in buxom women. The cut-outs 22 and longitudinalmidsection 23 help the electrode patch 15 fit nicely between a pair offemale breasts in the intermammary cleft. In one embodiment, thecut-outs 22 can be graduated to form the longitudinal midsection 23 as anarrow in-between stem or isthmus portion about 7 mm wide. In a stillfurther embodiment, tabs 24 can respectively extend an additional 8 mmto 12 mm beyond the distal and proximal ends of the flexible backing 20to facilitate purchase when adhering the electrode patch 15 to orremoving the electrode patch 15 from the sternum 13. These tabspreferably lack adhesive on the underside, or contact, surface of theelectrode patch 15. Still other shapes, cut-outs and conformities to theelectrode patch 15 are possible.

The monitor recorder 14 removably and reusably snaps into anelectrically non-conductive receptacle 25 during use. The monitorrecorder 14 contains electronic circuitry for recording and storing thepatient's electrocardiography as sensed via a pair of ECG electrodesprovided on the electrode patch 15, such as described incommonly-assigned U.S. patent application, entitled “Extended WearAmbulatory Electrocardiography and Physiological Sensor Monitor,” Ser.No. 14/080,725, filed Nov. 14, 2013, pending, the disclosure of which isincorporated by reference. The circuitry includes a microcontroller,flash storage, ECG signal processing, analog-to-digital conversion(where applicable), and an external interface for coupling to theelectrode patch 15 and to a download station for stored data downloadand device programming. The monitor recorder 14 also includes externalpatient-interfaceable controls, such as a push button to facilitateevent marking and a resonance circuit to provide vibratory output. In afurther embodiment, the circuitry, with the assistance of theappropriate types of deployed electrodes or sensors, is capable ofmonitoring other types of physiology, in addition to ECGs. Still othertypes of monitor recorder components and functionality are possible.

The non-conductive receptacle 25 is provided on the top surface of theflexible backing 20 with a retention catch 26 and tension clip 27 moldedinto the non-conductive receptacle 25 to conformably receive andsecurely hold the monitor recorder 14 in place. The edges of the bottomsurface of the non-conductive receptacle 25 are preferably rounded, andthe monitor recorder 14 is nestled inside the interior of thenon-conductive receptacle 25 to present a rounded (gentle) surface,rather than a sharp edge at the skin-to-device interface.

The electrode patch 15 is intended to be disposable. The monitorrecorder 14, however, is reusable and can be transferred to successiveelectrode patches 15 to ensure continuity of monitoring. The placementof the wearable monitor 12 in a location at the sternal midline 16 (orimmediately to either side of the sternum 13) benefits long-termextended wear by removing the requirement that ECG electrodes becontinually placed in the same spots on the skin throughout themonitoring period. Instead, the patient is free to place an electrodepatch 15 anywhere within the general region of the sternum 13.

As a result, at any point during ECG monitoring, the patient's skin isable to recover from the wearing of an electrode patch 15, whichincreases patient comfort and satisfaction, while the monitor recorder14 ensures ECG monitoring continuity with minimal effort. A monitorrecorder 14 is merely unsnapped from a worn out electrode patch 15, theworn out electrode patch 15 is removed from the skin, a new electrodepatch 15 is adhered to the skin, possibly in a new spot immediatelyadjacent to the earlier location, and the same monitor recorder 14 issnapped into the new electrode patch 15 to reinitiate and continue theECG monitoring.

During use, the electrode patch 15 is first adhered to the skin in thesternal region. FIG. 4 is a perspective view showing the extended wearelectrode patch 15 of FIG. 3 without a monitor recorder 14 inserted. Aflexible circuit 32 is adhered to each end of the flexible backing 20. Adistal circuit trace 33 from the distal end 30 of the flexible backing20 and a proximal circuit trace (not shown) from the proximal end 31 ofthe flexible backing 20 electrically couple ECG electrodes (not shown)to a pair of electrical pads 34. The electrical pads 34 are providedwithin a moisture-resistant seal 35 formed on the bottom surface of thenon-conductive receptacle 25. When the monitor recorder 14 is securelyreceived into the non-conductive receptacle 25, that is, snapped intoplace, the electrical pads 34 interface to electrical contacts (notshown) protruding from the bottom surface of the monitor recorder 14,and the moisture-resistant seal 35 enables the monitor recorder 14 to beworn at all times, even during bathing or other activities that couldexpose the monitor recorder 14 to moisture.

In addition, a battery compartment 36 is formed on the bottom surface ofthe non-conductive receptacle 25, and a pair of battery leads (notshown) electrically interface the battery to another pair of theelectrical pads 34. The battery contained within the battery compartment35 can be replaceable, rechargeable or disposable.

The monitor recorder 14 draws power externally from the battery providedin the non-conductive receptacle 25, thereby uniquely obviating the needfor the monitor recorder 14 to carry a dedicated power source. Thebattery contained within the battery compartment 35 can be replaceable,rechargeable or disposable. In a further embodiment, the ECG sensingcircuitry of the monitor recorder 14 can be supplemented with additionalsensors, including an SpO₂ sensor, a blood pressure sensor, atemperature sensor, respiratory rate sensor, a glucose sensor, an airflow sensor, and a volumetric pressure sensor, which can be incorporateddirectly into the monitor recorder 14 or onto the non-conductivereceptacle 25.

The placement of the flexible backing 20 on the sternal midline 16 (orimmediately to either side of the sternum 13) also helps to minimize theside-to-side movement of the wearable monitor 12 in the left- andright-handed directions during wear. However, the wearable monitor 12 isstill susceptible to pushing, pulling, and torquing movements, includingcompressional and torsional forces when the patient bends forward, andtensile and torsional forces when the patient leans backwards. Tocounter the dislodgment of the flexible backing 20 due to compressionaland torsional forces, a layer of non-irritating adhesive, such ashydrocolloid, is provided at least partially on the underside, orcontact, surface of the flexible backing 20, but only on the distal end30 and the proximal end 31. As a result, the underside, or contactsurface of the longitudinal midsection 23 does not have an adhesivelayer and remains free to move relative to the skin. Thus, thelongitudinal midsection 23 forms a crimp relief that respectivelyfacilitates compression and twisting of the flexible backing 20 inresponse to compressional and torsional forces. Other forms of flexiblebacking crimp reliefs are possible.

Unlike the flexible backing 20, the flexible circuit 32 is only able tobend and cannot stretch in a planar direction. FIG. 5 is a top viewshowing the flexible circuit 32 of the extended wear electrode patch 15of FIG. 3. A distal ECG electrode 38 and proximal ECG electrode 39 arerespectively coupled to the distal and proximal ends of the flexiblecircuit 32. The flexible circuit 32 preferably does not extend to theoutside edges of the flexible backing 20, thereby avoiding gouging ordiscomforting the patient's skin during extended wear, such as whensleeping on the side. During wear, the ECG electrodes 38, 39 must remainin continual contact with the skin. A strain relief 40 is defined in theflexible circuit 32 at a location that is partially underneath thebattery compartment 36 when the flexible circuit 32 is affixed to theflexible backing 20. The strain relief 40 is laterally extendable tocounter dislodgment of the ECG electrodes 38, 39 due to tensile andtorsional forces. A pair of strain relief cutouts 41 partially extendtransversely from each opposite side of the flexible circuit 32 andcontinue longitudinally towards each other to define in ‘S’-shapedpattern, when viewed from above. The strain relief respectivelyfacilitates longitudinal extension and twisting of the flexible circuit32 in response to tensile and torsional forces. Other forms of circuitboard strain relief are possible.

The flexible circuit 32 can be provided either above or below theflexible backing 20. FIG. 6 is a perspective view showing the extendedwear electrode patch 15 in accordance with a further embodiment. Theflexible circuit (not shown) is provided on the underside, or contact,surface of the flexible backing 20 and is electrically interfaced to theset of electrical pads 34 on the bottom surface of the non-conductivereceptacle 25 through electrical contacts (not shown) pierced throughthe flexible backing 20.

The electrode patch 15 is intended to be a disposable component, whichenables a patient to replace the electrode patch 15 as needed throughoutthe monitoring period, while maintaining continuity of physiologicalsensing through reuse of the same monitor recorder 14. FIG. 7 is anexploded view showing the component layers of the electrode patch 15 ofFIG. 3. The flexible backing 20 is constructed of a wearable gauze,latex, or similar wrap knit or stretchable and wear-safe material 44,such as a Tricot-type linen with a pressure sensitive adhesive (PSA) onthe underside, or contact, surface. The wearable material 44 is coatedwith a layer 43 of non-irritating adhesive, such as hydrocolloid, tofacilitate long-term wear. The hydrocolloid, for instance, is typicallymade of mineral oil, cellulose and water and lacks any chemicalsolvents, so should cause little itching or irritation. Moreover,hydrocolloid is thicker and more gel-like than most forms of PSA andprovides cushioning between the relatively rigid and unyieldingnon-conductive receptacle 25 and the patient's skin. In a furtherembodiment, the layer of non-irritating adhesive can be contoured, suchas by forming the adhesive with a concave or convex cross-section;surfaced, such as through stripes or crosshatches of adhesive, or byforming dimples in the adhesive's surface; or applied discontinuously,such as with a formation of discrete dots of adhesive.

As described supra with reference to FIG. 5, a flexible circuit can beadhered to either the outward facing surface or the underside, orcontact, surface of the flexible backing 20. For convenience, a flexiblecircuit 47 is shown relative to the outward facing surface of thewearable material 44 and is adhered respectively on a distal end by adistal electrode seal 45 and on a proximal end by a proximal electrodeseal 45. In a further embodiment, the flexible circuit 47 can beprovided on the underside, or contact, surface of the wearable material44. Through the electrode seals, only the distal and proximal ends ofthe flexible circuit 47 are attached to the wearable material 44, whichenables the strain relief 40 (shown in FIG. 5) to respectivelylongitudinally extend and twist in response to tensile and torsionalforces during wear. Similarly, the layer 43 of non-irritating adhesiveis provided on the underside, or contact, surface of the wearablematerial 44 only on the proximal and distal ends, which enables thelongitudinal midsection 23 (shown in FIG. 3) to respectively bow outwardand away from the sternum 13 or twist in response to compressional andtorsional forces during wear.

A pair of openings 46 is defined on the distal and proximal ends of thewearable material 44 and layer 43 of non-irritating adhesive for ECGelectrodes 38, 39 (shown in FIG. 5). The openings 46 serve as “gel”wells with a layer of hydrogel 41 being used to fill the bottom of eachopening 46 as a conductive material that aids electrode signal pick up.The entire underside, or contact, surface of the flexible backing 20 isprotected prior to use by a liner layer 40 that is peeled away, as shownin FIG. 8.

The non-conductive receptacle 25 includes a main body 54 that is moldedout of polycarbonate, ABS, or an alloy of those two materials to providea high surface energy to facilitate adhesion of an adhesive seal 53. Themain body 54 is attached to a battery printed circuit board 52 by theadhesive seal 53 and, in turn, the battery printed circuit board 52 isadhesed to the flexible circuit 47 with an upper flexible circuit seal50. A pair of conductive transfer adhesive points 51 or, alternatively,metallic rivets or similar conductive and structurally unifyingcomponents, connect the circuit traces 33, 37 (shown in FIG. 5) of theflexible circuit 47 to the battery printed circuit board 52. The mainbody 54 has a retention catch 26 and tension clip 27 (shown in FIG. 3)that fixably and securely receive a monitor recorder 14 (not shown), andincludes a recess within which to circumferentially receive a die cutgasket 55, either rubber, urethane foam, or similar suitable material,to provide a moisture resistant seal to the set of pads 34.

While the invention has been particularly shown and described asreferenced to the embodiments thereof, those skilled in the art willunderstand that the foregoing and other changes in form and detail maybe made therein without departing from the spirit and scope.

What is claimed is:
 1. An electrocardiography patch, comprising: aflexible backing formed of an elongated strip of stretchable material; apair of electrodes respectively affixed to and conductively exposed on acontact surface of each end of the elongated strip; a flexible circuitaffixed on each end to the elongated strip and comprising a pair ofcircuit traces both originating within one of the ends of the elongatedstrip and electrically coupled to each electrode; a non-conductivereceptacle securely adhered on the one end of the elongated stripopposite the contact surface and formed to removably receive anelectrocardiography monitor and house a battery below the receivedelectrocardiography monitor; electrical pads provided within amoisture-resistant seal formed on a bottom surface of the non-conductivereceptacle to interface with electrical contacts protruding from abottom surface of the electrocardiography monitor and a pair of theelectrical pads formed to electrically couple with the electrodes viathe circuit traces; and a pair of battery leads formed on thenon-conductive receptacle to electrically interface the battery toanother pair of the electrical pads.
 2. An electrocardiography patchaccording to claim 1, further comprising: one of the electrodes beingdisposed for being adhered to a region overlying the Xiphoid process ona patient's chest; and an other of the electrodes being disposed forbeing adhered to the region near the manubrium on the patient's chestoriented centrally (in the midline) along the sternum upwards from theone electrode.
 3. An electrocardiography patch according to claim 1,further comprising: an upper part of the elongated strip defined on oneend of the flexible backing and sized to be affixed to the bottomsurface of the non-conductive receptacle, the other of the electrodesbeing affixed to and conductively exposed on the contact surface of theupper part; and a lower part of the elongated strip defined on anotherend of the flexible backing; the one of the electrodes being affixed toand conductively exposed on the contact surface of the lower part,wherein the lower part of the elongated strip is provided for beingadhered to the region overlying the Xiphoid process on a patient's chestwith the narrow longitudinal midsection oriented centrally (in themidline) along the sternum and the upper part of the elongated striporiented upwards towards the manubrium.
 4. An electrocardiography patchaccording to claim 1, further comprising: a non-irritating adhesivedressing at least partially coated on each end of the elongated strip onthe contact surface.
 5. An electrocardiography patch according to claim4, further comprising: a contoured surface comprised on thenon-irritating adhesive dressing on at least one end of the elongatedstrip.
 6. An electrocardiography patch according to claim 1, furthercomprising: a plurality of fasteners comprised on the non-conductivereceptacle and oriented to securely receive and to hold captive theelectrocardiography monitor into the non-conductive receptacle.
 7. Anelectrocardiography patch according to claim 1, further comprising: atleast one of an SpO2 sensor, a blood pressure sensor, a temperaturesensor, respiratory rate sensor, a glucose sensor, an air flow sensor,and a volumetric pressure sensor provided to supplement theelectrocardiography monitor by one of direct incorporation into theelectrocardiography monitor and direct receipt on the non-conductivereceptacle.
 8. An electrocardiography patch according to claim 1,further comprising: a liner shaped to cover the contact surface of theflexible backing.
 9. An electrocardiography patch according to claim 1,wherein the flexible circuit is adhered to one of the contact surface ofthe flexible backing and a surface opposite the contact surface of theflexible backing.
 10. An electrocardiography patch according to claim 1,wherein the electrocardiography monitor draws power externally from thebattery provided in the non-conductive receptacle.
 11. Anelectrocardiography and physiological sensor monitor, comprising: adisposable extended wear electrode patch comprising: a flexible backingformed of an elongated strip of stretchable material; a pair ofelectrodes respectively affixed to and conductively exposed on a contactsurface of each end of the elongated strip; a flexible circuit affixedon each end to the elongated strip and comprising a pair of circuittraces both originating within one of the ends of the elongated stripand electrically coupled to each electrode; a non-conductive receptaclesecurely adhered on the one end of the elongated strip opposite thecontact surface and formed to house a battery; electrical pads providedwithin a moisture-resistant seal formed on a bottom surface of thenon-conductive receptacle and a pair of the electrical pads formed toelectrically couple with the electrodes via the circuit traces; and apair of battery leads formed on the non-conductive receptacle toelectrically interface the battery to another pair of the electricalpads; and a reusable electrocardiography monitor having a sealed housingadapted to be removably secured into the non-conductive receptacle,wherein the sealed housing comprises a cavity on a bottom surface toaccommodate the battery on the extended wear electrode patch andprotruding electrical contacts that interface with the electrical padson the non-conductive receptacle.
 12. An electrocardiography andphysiological sensor monitor according to claim 11, further comprising:one of the electrodes being disposed for being adhered to a regionoverlying the Xiphoid process on a patient's chest; and an other of theelectrodes being disposed for being adhered to the region near themanubrium on the patient's chest oriented centrally (in the midline)along the sternum upwards from the one electrode.
 13. Anelectrocardiography and physiological sensor monitor according to claim11, further comprising: an upper part of the elongated strip defined onone end of the flexible backing and sized to be affixed to the bottomsurface of the non-conductive receptacle, the other of the electrodesbeing affixed to and conductively exposed on the contact surface of theupper part; and a lower part of the elongated strip defined on anotherend of the flexible hacking; the one of the electrodes being affixed toand conductively exposed on the contact surface of the lower part,wherein the lower part of the elongated strip is provided for beingadhered to the region overlying the Xiphoid process on a patient's chestwith the narrow longitudinal midsection oriented centrally (in themidline) along the sternum and the upper part of the elongated striporiented upwards towards the manubrium.
 14. An electrocardiography andphysiological sensor monitor according to claim 11, further comprising:a non-irritating adhesive dressing at least partially coated on each endof the elongated strip on the contact surface.
 15. Anelectrocardiography and physiological sensor monitor according to claim14, further comprising: a contoured surface comprised on thenon-irritating adhesive dressing on at least one end of the elongatedstrip.
 16. An electrocardiography and physiological sensor monitoraccording to claim 11, further comprising: a plurality of fastenerscomprised on the non-conductive receptacle and oriented to securelyreceive and to hold captive the electrocardiography monitor into thenon-conductive receptacle.
 17. An electrocardiography and physiologicalsensor monitor according to claim 11, further comprising: at least oneof an SpO2 sensor, a blood pressure sensor, a temperature sensor,respiratory rate sensor, a glucose sensor, an air flow sensor, and avolumetric pressure sensor provided to supplement theelectrocardiography monitor by one of direct incorporation into theelectrocardiography monitor and direct receipt on the non-conductivereceptacle.
 18. An electrocardiography and physiological sensor monitoraccording to claim 11, further comprising: a liner shaped to cover thecontact surface of the flexible backing.
 19. An electrocardiography andphysiological sensor monitor according to claim 11, wherein the flexiblecircuit is adhered to one of the contact surface of the flexible backingand a surface opposite the contact surface of the flexible backing. 20.An electrocardiography and physiological sensor monitor according toclaim 11, wherein the electrocardiography monitor draws power externallyfrom the battery provided in the non-conductive receptacle.